Nothing in any other industry quite compares to the pharmaceutical industry's clinical development process. In 2007, $28 billion dollars were spent on drug development. Nowadays a single clinical trial can be capital intensive (up to $500 million), with massive geographic coverage (as many as 53 countries), long duration (five years or longer), and enroll a large number of patients (20,000- to 50,000-patient trials are no longer rare).
A median Phase III clinical trial involves about 800 patients, 50 investigator sites, and two years (700 days) from First Subject First Visit (FSFV) to Last Subject Last Visit (LSLV). Add in the costs of per-patient medical procedures, drug supplies, laboratory work, and sponsor's personnel, and a median-sized clinical trial can cost upwards of $25 million, about $36,000 every single day.
Clearly clinical trials are extremely important to the pharmaceutical industry both as the source for clinical data and as an enormous cost center. And the patient enrollment phase of a trial is the most variable part of the process—that is, the spot where we could most reasonably expect to drive down costs. But we still lack a fundamental understanding of patient enrollment as a business process. While many companies are attempting to manage trials better, it is not surprising to see that their approaches, even those of established industry experts, lack in structure and objectivity and occasionally make things worse—for example, by making false assumptions about who has final responsibility for recruiting patients.
There are ongoing and intensive efforts being made in drug development organizations around the world to improve the efficiency and effectiveness in clinical trial execution. There are many examples of successfully executed clinical trials based on better understanding and better planning of trials by those more experienced and more knowledgeable professionals. Successful clinical trials sometimes also resulted from a better designed and executed business processes by some of the drug development organizations. Clearly, we are also collectively benefiting from progresses being made in information technology. However, the learning and success in drug development operations are isolated, subjective, and difficult to be institutionalized for cross fertilization. Thus, there is a need to develop new methodology that would enable us to quantitatively identify and realize opportunities for improvement in clinical trial execution.